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P3: Pacemaker Patient Profiling Study

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ClinicalTrials.gov Identifier: NCT00294060
Recruitment Status : Terminated (Preliminary analysis determined there was sufficient data to support objectives and allow early completion. The last patient visit occurred on November 6, 2007.)
First Posted : February 20, 2006
Results First Posted : May 6, 2011
Last Update Posted : May 6, 2011
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
The P3 Study is a United States post market study to gather data on clinical status, primary indications, device therapy choices, clinical management and outcomes for patients with implantable pacemakers.

Condition or disease
Bradycardia

Study Type : Observational
Actual Enrollment : 2013 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pacemaker Patient Profiling (P3) Study
Study Start Date : March 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007



Primary Outcome Measures :
  1. Number of Participants With Dual Chamber Devices [ Time Frame: at original implant ]
    Pacemaker device choice characterized by the number of patients with dual chamber devices

  2. Days Hospitalized [ Time Frame: implant to one year ]
    Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year

  3. Multiple In-clinic Visits [ Time Frame: implant to one year ]
    Follow-up practice pattern assessed by the number of patients with a dual chamber device that had two or more routine pacemaker in-clinic visits with a device interrogation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
Criteria

Inclusion Criteria:

  • Patient meets Class I / Class II indications for pacing
  • Patient implanted with one of the following market-approved single or dual chamber Medtronic devices: EnRhythm™, EnPulse®, Kappa® 700, Kappa® 900, Vitatron Clarity™, Vitatron Selection® AFm, Vitatron C-Series, Vitatron T-Series, or the AT500™ DDDR Pacing System

Exclusion Criteria:

  • Patient is enrolled in a device or cardiovascular drug study that affects treatment and/or study device programming
  • Patient whose life expectancy is less than two years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294060


  Show 83 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Study Chair: Ravi Kanagala, MD Franciscan Skemp Healthcare

Responsible Party: P3 Study Team, Medtronic CRDM
ClinicalTrials.gov Identifier: NCT00294060     History of Changes
Other Study ID Numbers: 244
First Posted: February 20, 2006    Key Record Dates
Results First Posted: May 6, 2011
Last Update Posted: May 6, 2011
Last Verified: April 2011

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Pacemaker
Bradycardia

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes